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Sofosbuvir plus ribavirin for hepatitis C virus-associated cryoglobulinaemia vasculitis: VASCUVALDIC study
  1. David Saadoun1,2,3,4,
  2. Vincent Thibault5,
  3. Si Nafa Si Ahmed6,
  4. Laurent Alric7,
  5. Maxime Mallet8,
  6. Constance Guillaud9,
  7. Hassane Izzedine10,
  8. Aurélie Plaisier11,
  9. Hélène Fontaine12,
  10. Myrto Costopoulos13,
  11. Magali Le Garff-Tavernier13,
  12. Christophe Hezode14,
  13. Stanislas Pol12,
  14. Lucile Musset15,
  15. Thierry Poynard8,
  16. Patrice Cacoub1,2,3,4
  1. 1Inflammation-Immunopathology-Biotherapy Department (DHU i2B), Sorbonne Universités, UPMC Univ Paris 06, Paris, France
  2. 2INSERM, UMR_S 959, Paris, France
  3. 3CNRS, FRE3632, Paris, France
  4. 4Groupe Hospitalier Pitié-Salpêtrière, Department of Internal Medicine and Clinical Immunology, AP-HP, Paris, France
  5. 5Groupe Hospitalier Pitié-Salpétrière, Department of Virology, APHP, Paris, France
  6. 6Department of Hepatology, Hôpital Orléans, Orléans, France
  7. 7Department of Internal Medicine-Digestive, Centre hospitalier universitaire Purpan, UMR 152 Toulouse 3 University, Toulouse, France
  8. 8Groupe Hospitalier Pitié-Salpétrière, Department of Hepatology, AP-HP, Paris, France
  9. 9Department of Internal Medicine, Hôpital Henri Mondor, Créteil, France
  10. 10Groupe Hospitalier Pitié-Salpétrière, Department of Nephrology, APHP, Paris, France
  11. 11Department of Hepatology, APHP, Hôpital Beaujon, Clichy, France
  12. 12Department of Hepatology, APHP, Hôpital Cochin, Paris, France
  13. 13Groupe Hospitalier Pitié-Salpétrière, Biological Hematology, APHP, Paris, France
  14. 14Department of Hepatology, APHP, Hôpital Henri Mondor, Créteil, France
  15. 15Groupe Hospitalier Pitié-Salpétrière, Department of Immunology, UF d'Immunochimie et d'autoimmunité, APHP, Paris, France
  1. Correspondence to Dr David Saadoun, Department of Internal Medicine and Clinical Immunology, AP-HP, Hôpital Pitié-Salpêtrière, 83 boulevard de l'hôpital, Paris F-75013, France; david.saadoun{at} and Pr Patrice Cacoub;


Background Hepatitis C virus (HCV) is the aetiological agent for most cases of cryoglobulinaemia vasculitis. Interferon-containing regimens are associated with important side effects and may exacerbate the vasculitis.

Objective To evaluate safety and efficacy of an oral interferon-free regimen, sofosbuvir plus ribavirin, in HCV-cryoglobulinaemia vasculitis.

Patients and methods We enrolled 24 consecutive patients (median age of 56.5 years and 46% of women) with HCV-cryoglobulinaemia vasculitis. Sofosbuvir (400 mg/day) was associated with ribavirin (200–1400 mg/day), for 24 weeks. The primary efficacy end point was a complete clinical response of the vasculitis at the end of treatment (week 24).

Results Main features of HCV-cryoglobulinaemia vasculitis included purpura and peripheral neuropathy (67%), arthralgia (58%), glomerulonephritis (21%) and skin ulcers (12%). Twenty-one patients (87.5%) were complete clinical response at week 24. Complete clinical response was achieved in six (25%) patients at week 4, four (16.6%) at week 8, seven (29.2%) at week 12, three (12.5%) at week 16 and one (4.2%) at week 20. The cryoglobulin level decreased from 0.35 (0.16–0.83) at baseline to 0.15 (0.05–0.45) g/L at week 24. The C4 serum level increased from 0.10 (0.07–0.19) to 0.17 (0.09–0.23) g/L at week 24. Seventy-four per cent of patients had a sustained virological response at week 12 post treatment. The most common side effects were fatigue, insomnia and anaemia. Two serious adverse events were observed.

Conclusions Sofosbuvir plus ribavirin combination was associated with a high rate of complete clinical response and a low rate of serious adverse events in HCV-cryoglobulinaemia vasculitis.

  • Systemic vasculitis
  • Infections
  • Autoimmune Diseases

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